Opko Health, Inc. · NASDAQ:OPK
Opko Health — Investor Presentation (June 2018)
26 slides from Opko Health's investor presentation, Jun 6, 2018
Slide 1: June 2018
June 2018 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,
Slide 3: Multinational biopharmaceutical and diagnostics company in large, underserved markets
Multinational biopharmaceutical and diagnostics company establishing important positions in large, underserved markets June 2018 |
Slide 4: Multi-Faceted Growth Strategy
Multi-Faceted Growth Strategy SARM: BPH, Stress Incontinence NK-1: Overactive Bladder UROLOGY Factor VIIa: Hemophilia hGH: Growth hormone deficiency LA hGH Analog: Agromegaly IGF-1 CTP: GH receptor deficiency LA GLP-2: Short bowel syndrome LA Parathyroid Hormone LA Insulin HEMATOLOGY ENDOCRINOLOGY N
Slide 5: Investment Highlights
Investment Highlights Mature Diagnostic Business with ~900MM in revenue & growing Marketed Pharmaceuticals in early life-cycle with multi $B market opportunities in large underserved markets Robust Development Pipeline Multiple late-stage clinical trials addressing indications with large unmet medic
Slide 6: Robust Pipeline, Diagnostics, Diversified Assets
Robust Pipeline Diagnostics Diversified assets across business units RAYALDEE addresses unmet need in CKD market, ~9 million patients RAYALDEE partnered with Vifor Fresenius; Up to $837 million in milestones, double- digit royalties RAYALDEE partnered in Japan with Japan Tobacco; up to $112 mileston
Slide 7: Marketed Pharmaceuticals
Robust Pipeline Diagnostics Diversified Assets Early Life Cycle Pharmaceuticals Marketed Pharmaceuticals June 2018 |
Slide 8: Chronic Kidney Disease (CKD) – The Silent Killer
Chronic Kidney Disease (CKD) – The Silent Killer 9th Leading cause of death, ahead of breast and prostate cancer Prevalence expected to increase due to obesity, diabetes and hypertension Most patients die from cardiovascular disease, precipitated by secondary hyperparathyroidism (SHPT) SHPT is drive
Slide 9: RAYALDEE Overview
Extended-Release (1x daily) oral formulation of 25D3* addresses significant unmet need FDA-approved for SHPT (elevated PTH) in patients with stage 3-4 CKD and VDI Reduces plasma PTH and increases serum 25D with a safety profile similar to placebo Minimal effects on serum calcium or phosphorus (key d
Slide 10: RAYALDEE Sends Clear Message
RAYALDEE signals changes in treatment of SHPT First and only extended-release prohormone of active form of vitamin D3 Brings 25-hydroxyvitamin D levels up Brings iPTH levels down RAYALDEE® Sends Clear Message June 2018 |
Slide 11: RAYALDEE Commercialization
50-Person sales and marketing team launched RAYALDEE on November 30, 2016 Increased field sales force from 35 to 64 reps (October 2017) Commercial insurance under contract for >83% of U.S. covered lives Medicare Part D insurance under contract for >53% of U.S. covered lives Total RAYALDEE prescripti
Slide 12: Broad Development Pipeline
Robust Pipeline Diagnostics Diversified Assets Broad Development Pipeline Marketed Pharmaceuticals June 2018 |
Slide 13: Robust Late-Stage Pipeline
hGH-CTP (Somatrogon) hGH deficiency Adult Ph 3 completed YE16 Pediatric Ph 3 Initiated YE16 OPK88005 (Factor VIIa-CTP) Hemophilia A & B Ph 2a ongoing (Seeking Partner) OPK88003 (Oxyntomodulin) Diabetes, obesity Ph 2 initiated in 1Q 2018 OPK88004 (SARM) BPH Ph 2 initiated in 4Q 2017 OPK88001 (AntagoN
Slide 14: hGH-CTP Competitive Advantages
New molecular entity (NME) that maintains native sequence of growth hormone Once weekly injection vs. current products requiring daily injections Phase 3 study in growth hormone deficient adults completed at the end of 2016 Phase 3 study in naive growth hormone deficiency pediatric population underw
Slide 15: Phase 3 pediatric and adult hGH-CTP studies
Initiated Phase 3 pediatric hGH-CTP study in December 2016 220 patients, non-inferiority comparison of weekly hGH-CTP to daily growth hormone Global study sites initiated in December 2016 Easy-to-use, disposable, refrigerated pen device Phase 3 adult hGH-CTP In December 2016 reported that primary en
Slide 16: Selective Androgen Receptor Modulator (SARM)
Selective Androgen Receptor Modulator (SARM) 50 Million men in the U.S. are affected by BPH 90% Men 80 years old and older are affected by enlarged prostate1 14M Men in the U.S. with lower urinary tract symptoms suggestive of BPH1 1 Deters LA. Benign prostatic hypertrophy. Emedicine http://emedicine
Slide 17: Pruritus
Pruritus Acute and chronic pruritus (“itching”) occurs in 10% to 15% of the population Most prevalent in skin, kidney and liver diseases Substance P is implicated in pruritus NK-1 antagonists block substance P activity and have been shown to reduce itching in human trials Pruritus in Dialysis Patien
Slide 18: Oxyntomodulin Analog for Type 2 Diabetes and Obesity
Oxyntomodulin Analog for Treatment of Type 2 Diabetes and Obesity Phase 2 study in 420 type 2 diabetes patients (week 12) % HbA1c change from baseline % Body weight change from baseline % Patients with ≥ 5% weight loss p=0.025 Placebo OPK 50 mg Exenatide ER OPK-88003 Drug development focused on: blo
Slide 19: Core $900 MM Business and Growing
Robust Pipeline Diagnostics Diversified Assets Core $900 MM Business And Growing Marketed Pharmaceuticals June 2018 |
Slide 20: Leveraging National Marketing, Sales and Distribution Resources
Leveraging National Marketing, Sales and Distribution Resources to Drive Uptake of Diagnostic Platforms Over 12 million patients served during 2017 Revenue of ̴ $900MM in 2017; 4Q17 revenue of ̴ $150MM GeneDx is a genomics leader known for its expertise in rare disease and whole exome testing Utiliz
Slide 21: 4Kscore Test
More Than 2 Million Prostate Biopsies/Year WW Clinical utility based on decades of biomarker research and >20,000 men tested in Europe and U.S. In long-term outcome data, 4Kscore test can predict 20 year metastasis free survival for individual patient Included in the 2015-2017 NCCN and 2016-2017 EAU
Slide 22: 4Kscore reimbursement and CPT coverage
Category I CPT published and effective January 1, 2017; CMS national rate for 2018 increased to $760 vs $600 in 2017 Novitas Solutions (Medicare Administrative Contractor for OPKO Elmwood Park, NJ facility) Novitas issued a draft non-coverage determination in May 2018 subject to a public comment per
Slide 23: Claros 1 Platform Addresses Large Point of Care Test Market
25M PSA Tests in U.S. Annually; Novel diagnostic system can provide rapid, quantitative blood test results in 10 minutes – right in the physician’s office Modular PMA with FDA for PSA test filed in 4Q17; expect response 2H18 Expect testosterone 510(k) filing YE18 Claros 1 point of care platform will
Slide 24: Select Financial Information
Select Financial Information March 31, 2018 Cash, cash equivalents & marketable securities: $99.9 million Net investments: $297.5 million Current portion of line of credit and notes payable: $11.9 million Senior notes: $31.8 million $55 million convertible note issued February 2018 Common shares out
Slide 25: Upcoming milestones
Upcoming milestones Progress Across Multiple Business Areas 4Kscore Launched TV ads in FL 1Q18 Oxyntomodulin Phase 2b Initiated March 2018 RAYALDEE Stage 5 CKD Phase 2 Initiate 2H18 NK-1 Antagonist Pruritus Phase 2a Initiate 2H18 Claros 1 PSA approval 3Q18 SARM Phase 2 complete enrollment YE18 Claro
Slide 26: Thank You
Thank You